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临床试验/NCT04138784
NCT04138784Unknown不适用

Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women

Universidad de Granada0 个研究点目标入组 38 人开始时间: 2019年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
主要终点
Changes in Functionality

研究概览

简要总结

Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

详细描述

The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
  • Women aged older than 65 years
  • Pain predominantly over the last 3 months
  • Kellgren and Lawrence score ≥2.

排除标准

  • Ankle, hip or foot severe disorders
  • Chronic back pain
  • Alzheimer's disease, Parkinson's disease, motor neuron disorders.
  • Diabetes mellitus
  • Cardiac or respiratory insufficiency
  • Inability to understand the procedure

结局指标

主要结局

Changes in Functionality

时间窗: Baseline, 8 weeks, 3 months

Changes in Functionality is going to be assessed by the Western Ontario and McMaster Universities (WOMAC). Scores range from 0 to 96, with higher scores indicating greater disease severity.

Changes in Perceived Health Status

时间窗: Baseline, 8 weeks, 3 months

Changes in Perceived Health Status is going to be assessed by the EuroQol-5D.It contains two sections, a descriptive section and a valuation section. The descriptive section is a health status classification instrument with the following five dimensions: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. In the second section, respondents are asked to value their overall health status on a visual analogue scale ranging from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state)

Changes in Physical Performance

时间窗: Baseline, 8 weeks, 3 months

Changes in Physical Performance is going to be assessed using the Stairs Climbing Test. This test assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Assistant profressor

Universidad de Granada

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